Process Engineer- Medical Device Industry

We are growing and looking for an experienced Process Engineer to support development and manufacturing of assembly automation projects for medical and pharmaceutical delivery devices. Gilero partners with Tecma to operate a medical device manufacturing facility in Tijuana, Mexico. We are currently seeking a Process Engineer to join the TJ team!

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, collaboration and excellence!

Job Summary:

The position is responsible for developing new manufacturing systems for emerging technologies to support the production of medical devices under device regulations and standards (ISO 13485 and FDA 21 CFR Part 820). In this role, you will be responsible for designing and implementing manufacturing processes and supporting projects on a scale that can range from developmental pilots to full commercial production.

Duties:

• Specify and manage external build contractors, install, troubleshoot, and validate automated equipment and processes for complex device assembly and testing.
• Develop and deliver new manufacturing process capabilities as needed including process selection, characterization and qualification utilizing designed experiment methodology (DOE)
• Evaluate new device designs for manufacturability (DFM/DFA)
• Establish process flow and line layouts to achieve efficient, flexible, and scalable manufacturing cells
• Utilizes Lean Thinking, Six Sigma and 5S concepts when creating new or improving existing processes.
• Specify new process equipment for manual and fully-automated production lines
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
• Generate CAD models for test or assembly fixtures
• Establish maintenance requirements for new equipment
• Evaluate the impact of new processes introductions on critical environments
• Assess and implement process changes as required by customer request, in response to manufacturing quality issues, or design changes.
• Perform process risk analysis through PFMEA activities to support new or existing processes.
• Maintain Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and non-conformances.
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes.
• Support quality audits of manufacturing processes
• Drive Continuous Improvement activities within the manufacturing area to meet and exceed operational objectives and goals
• Develop processes and rates for customer quotations in response to inquiries while working with Tooling, Engineering, Purchasing, and Customer Service to obtain needed information
• Facilitate design transfer of existing products to and from other manufacturing sites.
• Lead project activities through the management of budgets, resources, timelines, and deliverables
• Provide engineering expertise in resolving specific technology issues during development and provide support to the production team during ramp and sustaining activities
• Communicate effectively with customers and vendors in a technical capacity

Skills/Qualifications:

• BS in Engineering or equivalent technical degree.
• Minimum 3 years relevant experience in manufacturing medical devices.
• Knowledge of medical device regulations (FDA/ISO)
• Experience with SolidWorks, Pro/Engineer and/or other 3D CAD modeling software, preferred.
• Experience with drug filling and handling for combination products, strong plus.
• Ability to program PLC, Arduino, or other motion controllers, strong plus.
• Experience incorporating vision systems into manufacturing equipment for use in in-process inspection and/or motion control, a plus.
• Excellent communication skills (oral and written)
• Proficient (or better) computer skills, including Excel and Word

Personal Attributes:

• Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients
• Commitment to excellence and quality service to external and internal customer
• Commitment to established policies and procedures, while contributing to continuous improvements

Why work at Gilero?

• Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continue to grow at a rapid pace. Locations include Tijuana, Mexico and US locations in Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.